
Wyntek Diagnostics, Inc.
Free shipping on orders over $99 · 30-day returns
OSOM HCG-URINE TEST MODEL 101 is an FDA 510(k)-cleared medical device (K974159) manufactured by Wyntek Diagnostics, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 23, 1997. Regulation: 8.